Clinical Trials List
Protocol NumberAC-701-ONC-002
2018-12-31 - 2020-12-31
Phase II
Recruiting2
ICD-10R21
Rash and other nonspecific skin eruption
A Randomized, Double-Blind, Placebo-Controlled Trial of AC-701 For Treatment of Skin Rash in Subjects with EGFR Inhibitor Therapy
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Trial Applicant
TWI BIOTECHNOLOGY, INC
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Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- DINGDAR LEE Division of Dermatology
- Cheng-Yuan Li Division of Dermatology
- Yun-Ting Chang Division of Dermatology
- 吳貞宜 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
CRO
Co-Principal Investigator
- Chun-Bing Chen Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Skin Rash in Subjects with EGFR Inhibitor Therapy
Objectives
Primary objective:
To evaluate the efficacy of topical treatment with AC-701 in subjects with skin rash associated with EGFRI therapy
Secondary objectives:
To determine the effect of topical treatment with AC-701 on subject quality of life
To evaluate the safety and tolerability of topical treatment with AC-701 in subjects with skin rash associated with EGFRI therapy
Test Drug
AC-701(Berberine) Gel:0.3%
Active Ingredient
Berberine
Dosage Form
Gel
Dosage
0.3
Endpoints
Primary Endpoint:
• Proportion of subjects requiring rescue therapy by Week 8
Secondary Endpoints:
• Proportion of subjects with MESTT Grade 1A, 1B, 2A, 2B, 3A or 3B facial skin rash at Week 8
to evaluate subjects with 1 or no grade reduction
• Proportion of subjects with CEA Grade 0, 1, 2, 3, or 4 facial erythema at Week 8 to evaluate
subjects with 2, 1, or no grade reduction
• Change from baseline of facial lesion counts at Week 8
• Change from baseline of facial area involvement at Week 8
• Subject-rated visual analog scale (VAS) pruritus and pain scores at Week 8
• Subject-rated quality of life questionnaires at Week 8
• Incidence of adverse events during the treatment period
Exploratory Endpoints:
• Change from baseline of MESTT grading at Week 8
• Change from baseline of CEA grading at Week 8
• Facial rash components at Week 8
• Facial Image Collection
• Proportion of subjects requiring rescue therapy by Week 8
Secondary Endpoints:
• Proportion of subjects with MESTT Grade 1A, 1B, 2A, 2B, 3A or 3B facial skin rash at Week 8
to evaluate subjects with 1 or no grade reduction
• Proportion of subjects with CEA Grade 0, 1, 2, 3, or 4 facial erythema at Week 8 to evaluate
subjects with 2, 1, or no grade reduction
• Change from baseline of facial lesion counts at Week 8
• Change from baseline of facial area involvement at Week 8
• Subject-rated visual analog scale (VAS) pruritus and pain scores at Week 8
• Subject-rated quality of life questionnaires at Week 8
• Incidence of adverse events during the treatment period
Exploratory Endpoints:
• Change from baseline of MESTT grading at Week 8
• Change from baseline of CEA grading at Week 8
• Facial rash components at Week 8
• Facial Image Collection
Inclution Criteria
Inclusion Criteria:
1. Is between 20 and 80 years of age, inclusive.
2. Has MESTT Grade 2A or 2B skin rash on the face.
3. Is currently receiving EGFR inhibitor therapy as indicated for a cancer, and no prior use history.
4. Has a life expectancy of at least three months.
5. Is male, or is female and meets all the following criteria:
a. Not breastfeeding.
b. If of childbearing potential (defined as non-post-hysterectomy or non-post-menopausal
[≥50 years of age and amenorrheic for at least one year]), must have a negative pregnancy
test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 1, and must
practice and be willing to continue to practice appropriate birth control (abstinence, double
barrier methods, hormonal contraceptives, intrauterine device, or tubal ligation) during the
entire duration of the study.
6. Is able to read, understand, and sign the Informed Consent Form (ICF), answer the study
questionnaires, communicate with the investigator, and understand and comply with protocol
requirements.
1. Is between 20 and 80 years of age, inclusive.
2. Has MESTT Grade 2A or 2B skin rash on the face.
3. Is currently receiving EGFR inhibitor therapy as indicated for a cancer, and no prior use history.
4. Has a life expectancy of at least three months.
5. Is male, or is female and meets all the following criteria:
a. Not breastfeeding.
b. If of childbearing potential (defined as non-post-hysterectomy or non-post-menopausal
[≥50 years of age and amenorrheic for at least one year]), must have a negative pregnancy
test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 1, and must
practice and be willing to continue to practice appropriate birth control (abstinence, double
barrier methods, hormonal contraceptives, intrauterine device, or tubal ligation) during the
entire duration of the study.
6. Is able to read, understand, and sign the Informed Consent Form (ICF), answer the study
questionnaires, communicate with the investigator, and understand and comply with protocol
requirements.
Exclusion Criteria
Exclusion Criteria:
1. Has any active dermatological conditions of the face that may interfere with the diagnosis,
assessment, or treatment of face skin rash associated with targeted cancer therapy.
2. Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to
Day 1.
3. Has been treated with oral antibiotics with anti-inflammatory effect (such as doxycycline or
minocycline) within 28 days prior to Day 1.
4. Is currently treated with target therapy other than EGFR inhibitor.
5. Receive prior treatment with any investigational product within 28 days prior to Day 1.
6. Has hypersensitivity or allergy to berberine.
7. Has any other significant diseases, conditions, or laboratory values which, in the opinion of the
investigator, might make participation not in the subject’s best interest or confound the
interpretation of study results.
8. Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted)
of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with
the study at the clinical study site.
9. Is employed by sponsor (i.e., is an employee, temporary contract worker, or designee responsible
for the conduct of the study).
1. Has any active dermatological conditions of the face that may interfere with the diagnosis,
assessment, or treatment of face skin rash associated with targeted cancer therapy.
2. Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to
Day 1.
3. Has been treated with oral antibiotics with anti-inflammatory effect (such as doxycycline or
minocycline) within 28 days prior to Day 1.
4. Is currently treated with target therapy other than EGFR inhibitor.
5. Receive prior treatment with any investigational product within 28 days prior to Day 1.
6. Has hypersensitivity or allergy to berberine.
7. Has any other significant diseases, conditions, or laboratory values which, in the opinion of the
investigator, might make participation not in the subject’s best interest or confound the
interpretation of study results.
8. Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted)
of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with
the study at the clinical study site.
9. Is employed by sponsor (i.e., is an employee, temporary contract worker, or designee responsible
for the conduct of the study).
The Estimated Number of Participants
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Taiwan
94 participants
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Global
94 participants
